REduce BlAdder CAncer REcurrence in patients treated for upper urinary tract urothelial carcinoma (REBACARE Trial) - REBACARE TRIA

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 190 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•- Patients with histologically proven urothelial carcinoma of the UUT with or
•without concurrent carcinoma in situ (CIS only is also allowed) or patients
•with a suspicion of a urothelial carcinoma of the UUT on CTscan with or without
•a urinary cytology sample suspicious of the presence of high-grade urothelial
•carcinoma. In case urinary cytology shows no abnormality and no diagnostic URS
•is done, conclusive results of the CT-urography are sufficient for inclusion
•and the coordinating
•investigator will evaluate the eligibility of the subject in consultation with
•the local investigator.
•- Patients treated either by partial ureterectomy or by a radical
•nephro-ureterectomy (open or laparoscopic) including a bladder cuff.
•- Age >= 18 years.
•- WHO performance status 0,1, or 2.
•- Negative pregnancy test in women with childbearing potential.
•- Written informed consent.

•- If pre-operative histology obtained by biopsy: aberrant histology of the UUT
•tumor of >50% (adenocarcinoma, small cell carcinoma, squamous cell
•carcinoma).
•- Postoperative pathological report shows absence of tumor (pT0) or >50% of the
•UUT tumor shows aberrant histology.
•- History or presence of a malignant tumor or carcinoma in situ of the bladder.
•- History of UUT urothelial carcinoma on the contralateral side or presence of
•bilateral UUT urothelial carcinoma.
•- Known allergy against Mitomycin.
•- Anticipated adjuvant intravesical treatment with chemo- or immunotherapy.
•- Anticipated adjuvant intravesical treatment with chemo- or immunotherapy
•following a diagnostic URS.
•- Acute urinary tract infection at the time of inclusion as assessed by urinary
•- Lymphadenopathy or distant metastases as assessed by preoperative CT-scan of
•thorax and abdomen.
•- Any other concurrent severe or uncontrolled disease preventing the safe
•administration of intravesical Mitomycin.
•- Breastfeeding women.

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